Senior Clinical Data Coder

The Senior Clinical Data Coder is primarily responsible for leading and overseeing activities related to the coding of clinical data across multiple ongoing studies. In addition to performing accurate coding tasks, the Senior Coder takes ownership of the coding module setup, establishes conventions, and drives the prioritization of coding deliverables. This role includes leadership responsibilities and active participation in the design, oversight, and continuous improvement of coding processes. The Senior Clinical Data Coder will conduct all activities in alignment with applicable regulatory requirements, industry guidelines, and Indero SOPs, while ensuring sponsor timelines and expectations are consistently met.

Key Responsibilities

• Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions.
• Oversee the setup of the coding module for assigned studies, ensuring correct configurations and workflows.
• Define, document, and manage coding conventions and ensure consistent application across studies.
• Act as the Lead Coder, coordinating coding activities across multiple studies simultaneously.
• Manage coding priorities, balancing workload across timelines and studies.
• Develop and maintain coding guidelines and synonym lists.
• Provide input to the Coding section of Data Management Plans.
• Oversee and perform dictionary up-versioning and related upgrade activities.
• Validate and test coding setups, programming of coding reports, and related database checks.
• Support data review activities and resolve data clarifications in a timely manner.
• Provide mentorship and guidance to junior or back-up coders.
• Actively contribute to process optimization, SOP development, and best practices in coding.
• Maintain effective communication with Data Management Leads, CRAs, and other stakeholders.

Requirements:

• Bachelor's degree or equivalent in pharmacy, life sciences, or a related field (medical/nursing background also acceptable).
• Minimum of 5 years' relevant experience in clinical data coding within clinical trials or the pharmaceutical/CRO environment.
• Thorough knowledge of medical terminology and medical dictionaries (MedDRA, WHO Drug).
• Demonstrated experience with coding module setup, management of conventions, and prioritization of tasks across multiple studies.
• Experience in query management and clinical data review.
• Proven ability to manage multiple studies concurrently.
• Excellent written and verbal English communication skills.
• Strong organizational and analytical skills with high attention to detail.
• Ability to lead within a global team environment, providing guidance to colleagues and ensuring deliverables are met.
• Good knowledge of GCP and applicable Health Canada, FDA, and EMA regulations/guidelines.

Our company:

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule
• Permanent full-time position
• Company benefits package
• Ongoing learning and development

About Indero

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero only accepts applicants who can legally work in India.

Brand name:

Indero